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Validation engineer

Sligo
Pe Global
Validation engineer
Posted: 6 December
Offer description

PE Global is recruiting for a Validation Engineer for a leading pharmaceutical clients based in Sligo. This is an initial 12-month contract, fully onsite position.Purpose:To coordinate the development and maintenance of the company's validation program incompliance with all applicable regulatory and company requirements.Co-ordination, implementation and active participation in the site Validation Program.Responsibilities:•Ensure all Computerized systems are qualified in compliance with Data Integrity policiesand regulatory requirements.•Co-ordination / direction and active participation in the validation of site equipment,facilities, utilities, processes and software in compliance with company policies, FDA,European cGMP and GAMP standards.•Generation/maintenance of the Validation Master Plans.•Generation/maintenance of Project Validation Plans.•Generation of validation plans, protocols and final reports to cGMP standard.•Understanding of Risk based equipment qualification, Equipment Risk Assessments, Critical Elements Test Plan development•Review / approval of all protocols and final reports.•Management of validation change control process.•Adheres to and supports all EHS & E standards, procedures and policiesQualifications:•3rd level qualification in a relevant engineering or scientific discipline.Job/Technical Skills•A minimum of 5-10 years' experience in a cGMP regulated environment.•A good understanding of regulatory requirements.•Must have hands on experience of execution of IQ/OQ/PQ for Facilities/ Utilities/ Equipment in Pharmaceuticals or Medical Devices or DiagnosticsInterested candidates should submit an updated CV.Please click the link below to apply, or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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